AstraZeneca, Janssen nearing initial clearance by PH COVID-19 vaccine expert panel

Kristine Sabillo, ABS-CBN News

Posted at Dec 04 2020 01:24 PM | Updated as of Dec 04 2020 01:29 PM

MANILA — The vaccine expert panel of the Philippines on Friday said that two vaccine developers might soon be given initial clearance for their proposed clinical trials in the country.

Dr. Nina Gloriani, University of the Philippines College of Public Health professor and head of the Department of Science and Technology’s vaccine technical panel, said they are just waiting for the response of pharmaceutical firms AstraZeneca and Janssen to their follow-up questions.

Once they are satisfied with the answers, their application may then be forwarded to the ethics review board. Once cleared by the board, they can undergo final evaluation by the Food and Drug Administration.

“We just have a few more comments. If they respond to that we should be granting technical clearance,” Gloriani said of AstraZeneca, which recently received regulatory approval in the United Kingdom. 

The Philippine private sector also recently signed a supply deal with the British vaccine manufacturer if it passes local regulations.

She said while the company was the last to submit, it was able to immediately send its documents including the required technical dossier. 

As for Janssen, which is under Johnson & Johnson, Gloriani said they had to defer action while waiting for their response. The company finally replied on December 2.

She said the vaccine expert panel will have to meet again and discuss the response. 

“If we are satisfied with their responses we will actually approve technical clearance,” she said.

Currently, only Chinese companies Sinovac and Clover Biopharmaceuticals have passed the vaccine expert panel. 

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The DOST said last week that the ethics review would only take a few days more. 

Of the 5 vaccine developers that applied for clinical trials, only Gamaleya Institute from Russia has not submitted complete documents.

“They have provided us with animal studies Phases I and II data. But their Phase 3 study protocol… still has some missing information. So we have requested that. And the informed consent has not been submitted,” Gloriani said.

She said that delays in the clinical trial application are mostly because of clarifications in the technical dossier. While some vaccine developers already published their interim findings, Gloriani said they cannot rely on published papers alone, especially if they are not peer-reviewed. 

"Gamaleya has somehow provided information that they have 92% efficacy. We want the scientific data. We cannot rely on what is published in the internet,” she said.